Magellan 8881850210Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521000537), received between Jun 15, 2017 and Oct 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY WERE ADMINISTERING A FLU VACCINATION AND PRIMED THE NEEDLE WITH NO INCIDENT. THEN, PART WAY THROUGH THE INJECTION, THE FLUID SHOT OUT OF THE SIDE. UPON INSPECTION THERE WAS A CRACK UNDERNEATH THE NEEDLE GUARD. ADDITIONAL INFORMATION RECEIVED ON 18OCT2024 STATED THAT THERE WAS NO INJURY TO THE PATIENT DURING THIS INCIDENT. THEY WERE UNABLE TO DETERMINE THE AMOUNT OF VACCINE THE PATIENT RECEIVED HOWEVER NO OTHER NEEDLE WAS USED TO COMPLETE THE VACCINE AS THE VIAL WAS EMPTY AT THE TIME THE FLUID EJECTED FROM THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20527565 ↗MalfunctionJun 15, 2017Break; Break
THE CUSTOMER REPORTED THE NEEDLESS HUB CONNECTION BROKE IN THE RECEIVING END OF THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 6643988 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.